Editor, – The editorial about the injunction (Aust Prescr 2006;29:120)noted that the judge felt the public interest would be best served by the regulatory authorities examining the evidence supporting the efficacy of Ginkgo biloba.
In June 2006 a complaint about the promotion of Tebonin brand of Ginkgo biloba was sent to the:
- Therapeutic Goods Administration (TGA) which has jurisdiction over the pack and package insert
- Complaints Resolution Panel which deals with advertisements in printed media and the internet
- Complaints Resolution Committee of the Complementary Healthcare Council of Australia which investigates complaints about pharmacy posters, leaflets, fax and direct mail.
The TGA response was classified 'commercial-in-confidence'. However, the TGA did note that the indications for Tebonin changed in July 2006 from 'For the symptomatic relief of tinnitus' to 'May assist in the management of tinnitus'.
In October 2006 the Complaints Resolution Committee suggested that issues relating to the product's efficacy should be referred to the TGA.
In November 2006 the Complaints Resolution Panel determined that promotional statements about Tebonin made in print media and the internet breached the Therapeutic Goods Advertising Code. Schwabe Pharma Australia was requested to withdraw the advertisements from further publication and not use similar representations in the future.1
In December 2006 the Tebonin pack and insert continued to state that Tebonin was 'an effective treatment' for tinnitus. Print advertisements, although slightly changed, still claimed the product offered 'relief' from tinnitus without the TGA qualifier 'may'.2A number of Australian internet pharmacy sites also continued to promote Tebonin as an 'effective treatment' for tinnitus.
The Tebonin case suggests that confidence in Australian regulatory authorities may be misplaced.
Ken Harvey
Adjunct Senior Research Fellow
School of Public Health, La Trobe University
Bundoora, Vic.
